The PERISCOPE II trial randomised 102 adults with gastric adenocarcinoma and limited peritoneal metastases (Peritoneal Cancer Index <7 or positive cytology) who had not progressed on ≥3 cycles of systemic therapy, to either continued systemic therapy alone (n=51) or gastrectomy plus cytoreductive surgery and HIPEC with oxaliplatin and docetaxel (n=51), with overall survival as the primary endpoint (median follow-up 67 months).
No survival benefit was seen with surgery plus HIPEC: median OS was 15.7 months in the experimental group vs 16.6 months in the standard group (HR 1.10, 95% CI 0.69–1.74; p=0.70). The surgical arm had substantially more harm: grade ≥3 adverse events in 42% vs 20%, serious adverse events in 44% vs 6%, and three treatment-related deaths (all in the surgical arm) within 100 days.
- Trial closed prematurely after an unplanned interim futility analysis, leaving it underpowered for its original sample size target. - Small total sample (n=102) limits precision of subgroup conclusions. - Restricted to European tertiary centres, limiting generalisability to lower-volume settings.
Do not add gastrectomy with cytoreductive surgery and HIPEC to systemic therapy for gastric cancer with limited peritoneal metastases — it offers no survival gain and substantially increases serious complications and treatment-related mortality. Systemic therapy alone remains the standard of care for this population.
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